- Apixaban was associated with lower event rates for all safety endpoints compared with warfarin (except for GI bleeding in the >120 kg category)
- There was a significant interaction between weight and study treatment for the ISTH major bleeding, suggesting warfarin was associated with a higher risk of major bleeding in the lower weight range compared with the higher weight categories; this was not seen with the use of apixaban
| Event – Safety endpoints | Rate per 100 patient-years (n) | HR (95% CI) | Interaction P value* |
||
|---|---|---|---|---|---|
| Apixaban | Warfarin | Apixaban vs warfarin | |||
| Major bleeding |
|
.0158 | |||
| ≤60 kg | 2.33 (36) | 4.28 (62) | 0.55 (0.36-0.82) |
|
|
| 61 to 120 kg | 2.15 (277) | 3.02 (379) | 0.71 (0.61-0.83) |
|
|
| >120 kg | 1.55 (13) | 2.08 (19) | 0.74 (0.37-1.50) |
|
|
| Major or CRNM bleeding |
|
.0108 | |||
| ≤60 kg | 3.60 (55) | 7.06 (101) | 0.51 (0.37-0.71) |
|
|
| 61 to 120 kg | 4.20 (532) | 5.97 (730) | 0.71 (0.63-0.79) |
|
|
| >120 kg | 2.77 (23) | 4.83 (43) | 0.58 (0.35-0.95) |
|
|
| Intracranial bleeding |
|
.1833 | |||
| ≤60 kg | 0.32 (5) | 1.49 (22) | 0.21 (0.08-0.56) |
|
|
| 61 to 120 kg | 0.35 (46) | 0.75 (96) | 0.47 (0.33-0.67) |
|
|
| >120 kg | 0.00 (0) | 0.43 (4) | - |
|
|
| GI bleeding |
|
.1730 | |||
| ≤60 kg | 0.90 (14) | 1.09 (16) | 0.84 (0.41-1.72) |
|
|
| 61 to 120 kg | 0.67 (87) | 0.79 (100) | 0.85 (0.64-1.13) |
|
|
| >120 kg | 0.47 (4) | 0.33 (3) | 1.44 (0.32-6.42) |
|
|
| Any bleeding |
|
.1101 | |||
| ≤60 kg | 18.68 (244) | 30.86 (344) | 0.62 (0.53-0.73) |
|
|
| 61 to 120 kg | 18.15 (1987) | 25.29 (2528) | 0.73 (0.69-0.78) |
|
|
| >120 kg | 16.44 (119) | 25.13 (176) | 0.67 (0.53-0.85) |
|
|
Favors apixaban
Favors warfarin
